Benzeneacetic acid, 2,4,5-trifluoro-

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

466-070-3

EC Name:

-

Cas Number:

209995-38-0

Molecular formula:

C8H5F3O2

IUPAC Name:

2-(2,4,5-trifluorophenyl)acetic acid

Method

Target gene:

histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Concentration range in the main test (with an without metabolic activation): 31.6, 100, 316, 1000, 5000 µg/plate

Vehicle / solvent:

Solvent: DMSO

Details on test system and experimental conditions:

Metabolic activation system: Male Wistar rats were induced with Phenobarbital(80 mg/kg
bw) and beta-naphthoflavone (100 mg/kg bw).

Quality control performed by Bioservice:

- biological activity in the salmonella assay

- sterility test

A stock of the supernatant containing the microsomes was frozen in ampoules of 2 and 5 ml and stored at <-75°C.

The protein concentration in S9 preparation was 31 mg/ml.

100 mM sodium-ortho-phosphat-buffer, pH 7.4 were ice-cold added to the following reagents to give final concentration in the S9 mix of:

8 mM MgCl2

33 mM KCl

5 mM Glucose-6-phosphate

5 mM NADP


This solution was immediately filter-sterilised and mixed with the liver 9000 x g supernatant fluid in the following proportion:

co-factor solution 9.6 parts

liver preparation 0.4 parts


During the experiment the S9 mix was stored on ice.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 4

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 ug/plate In experiment I.

Test results 5

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 ug/plate Experiment II.

Test results 6

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 2500 µg/plate and higher Experiment I.

Test results 7

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate Experiment II.

Applicant's summary and conclusion

Conclusions:

Trifluorophenyl acetic acid sample did not caused gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore it is considered to be non-mutagenic in the performed bacterial reverse mutation assay.